Efficacy and Safety of Efpeglenatide Versus Placebo in Pa... | NCT03353350

ID	Type	Description	Link
2016-001857-42
U1111-1182-1806	Other Identifier	UTN

Name	Class
Sanofi	INDUSTRY

Label	Type	Description	Intervention Names
Efpeglenatide 2mg	Experimental	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks	Drug: efpeglenatide (SAR439977)
Efpeglenatide 4 mg	Experimental	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)	Drug: efpeglenatide (SAR439977)
Efpeglenatide 6 mg	Experimental	Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)	Drug: efpeglenatide (SAR439977)
Placebo	Placebo Comparator	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
efpeglenatide (SAR439977)	Drug	Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2mg Efpeglenatide 4 mg

Measure	Description	Time Frame
Change in Glycated Hemoglobin (HbA1c) (%)	Change from Baseline to Week 30 in HbA1c	Baseline to Week 30

Measure	Description	Time Frame
Change in HbA1c (%)	Change from Baseline to Week 56 in HbA1c	Baseline to Week 56
Change in Fasting Plasma Glucose (FPG)	Change from Baseline to Week 30 in FPG

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Participants must be at least 18 years of age at the time of signing the informed consent.
Participants with T2DM, and treated with diet and exercise.
Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory at Screening.

Exclusion criteria:

Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to) gastroparesis, unstable and not controlled gastroesophageal reflux disease within 6 months prior to Screening or history of surgery affecting gastric emptying.
History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy has been performed) and pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, and pancreatectomy.
Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions that predisposes to MTC (eg multiple endocrine neoplasia syndromes).
Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months of screening) or planned: intravitreal injections or laser or vitrectomy surgery.
Body weight change of ≥5 kg within the last 3 months prior to Screening.
Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at Randomization.
End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by Modification of Diet in Renal Disease [MDRD]) of <15 mL/min/1.73 m2.
Laboratory findings at the Screening Visit:
Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) >3 times the upper limit of the normal (ULN ) or total bilirubin >1.5 times the ULN (except in case of documented Gilbert's syndrome).
Amylase and/or lipase: >3 times the ULN laboratory range.
Calcitonin ≥5.9 pmol/L (20 pg/mL).
Gastric surgery or other gastric procedures intended for weight loss within 2 years prior to Screening, or planned during study period.
History of drug or alcohol abuse within 6 months prior to the time of Screening.
Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.
Women of childbearing potential not willing to use highly effective method(s) of birth control during the study period and for at least 5 weeks after the last dose of study intervention.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 8400004		Birmingham	Alabama	35205	United States
Investigational Site Number 8400005

PubMed Identifier	Type	Citation	Retractions
35671039	Derived	Frias JP, Choi J, Rosenstock J, Popescu L, Niemoeller E, Muehlen-Bartmer I, Baek S. Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial. Diabetes Care. 2022 Jul 7;45(7):1592-1600. doi: 10.2337/dc21-2656.

ID	Title	Description
FG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous
FG001	Efpeglenatide 2 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 7, 2018	Sep 13, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Glycated Hemoglobin (HbA1c) (%)

Change from Baseline to Week 30 in HbA1c

Posted

Mean

Standard Deviation

HbA1c (%)

Baseline to Week 30

ID	Title	Description
OG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG001	Efpeglenatide 2 mg	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG002	Efpeglenatide 4 mg	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG003	Efpeglenatide 6 mg	Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous

Units	Counts
Participants	OG000102 OG001100 OG002101 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.46± 1.16 OG001-1.14± 0.96 OG002-1.48± 1.01 OG003

Secondary

Change in HbA1c (%)

Change from Baseline to Week 56 in HbA1c

Posted

Mean

Standard Deviation

HbA1c (%)

Baseline to Week 56

ID	Title	Description
OG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG001	Efpeglenatide 2 mg	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG002	Efpeglenatide 4 mg	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG003	Efpeglenatide 6 mg	Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous

Secondary

Change in Fasting Plasma Glucose (FPG)

Change from Baseline to Week 30 in FPG

Posted

Mean

Standard Deviation

FPG (mmol/L)

Baseline to Week 30

ID	Title	Description
OG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG001	Efpeglenatide 2 mg	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG002	Efpeglenatide 4 mg	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG003	Efpeglenatide 6 mg	Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous

Secondary

HbA1c <7%

Number of participants with HbA1c <7.0% at Week 30

Posted

Count of Participants

Participants

Week 30

ID	Title	Description
OG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG001	Efpeglenatide 2 mg	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG002	Efpeglenatide 4 mg	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG003	Efpeglenatide 6 mg	Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous

Secondary

Change in Body Weight at Week 30

Change from Baseline to Week 30 in body weight

Posted

Mean

Standard Deviation

Baseline to Week 30

ID	Title	Description
OG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG001	Efpeglenatide 2 mg	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG002	Efpeglenatide 4 mg	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG003	Efpeglenatide 6 mg	Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous

Secondary

Change in Body Weight at Week 56

Change from Baseline to Week 56 in body weight

Posted

Mean

Standard Deviation

Baseline to Week 56

ID	Title	Description
OG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG001	Efpeglenatide 2 mg	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG002	Efpeglenatide 4 mg	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG003	Efpeglenatide 6 mg	Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous

Secondary

Hypoglycemic Participants

Number of participants with at least 1 hypoglycemic event during treatment period

Safety population: All participants randomly assigned to IMP and who take at least 1 dose of IMP. Participants were analyzed according to the treatment they actually received.

Posted

Count of Participants

Participants

Baseline to Week 56

ID	Title	Description
OG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG001	Efpeglenatide 2 mg	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG002	Efpeglenatide 4 mg	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG003	Efpeglenatide 6 mg

Secondary

Hypoglycemic Events

Number of hypoglycemic events

Safety population: All participants randomly assigned to IMP and who take at least 1 dose of IMP. Participants were analyzed according to the treatment they actually received.

Posted

Number

Number of events

Baseline to Week 56

ID	Title	Description
OG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG001	Efpeglenatide 2 mg	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG002	Efpeglenatide 4 mg	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG003	Efpeglenatide 6 mg

Secondary

Treatment Emergent Adverse Events (TEAEs)

Number of participants with TEAEs

Safety population: All participants randomly assigned to IMP and who take at least 1 dose of IMP. Participants were analyzed according to the treatment they actually received.

Posted

Number

Number of Treatment Emergent AEs

Baseline to Week 56

ID	Title	Description
OG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG001	Efpeglenatide 2 mg	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG002	Efpeglenatide 4 mg	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
OG003	Efpeglenatide 6 mg

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cystitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG0031 events1 affected99 at risk
Epiglottitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Meningitis viral	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected103 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected103 at risk EG003
Sepsis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected103 at risk EG003
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected103 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Depression	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Panic attack	Psychiatric disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Stress	Psychiatric disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected103 at risk EG003
Vertebral artery stenosis	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Cerebral artery stenosis	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected103 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected103 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Chest pain	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected103 at risk EG003
Foreign body in respiratory tract	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Heat stroke	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected103 at risk EG003
Pneumoconiosis	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Chronic left ventricular failure	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected102 at risk EG0020 events0 affected103 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected102 at risk EG0010 events0 affected102 at risk EG0021 events1 affected103 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected102 at risk EG0020 events0 affected103 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0008 affected102 at risk EG00110 affected102 at risk EG0027 affected103 at risk EG00311 affected99 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0007 affected102 at risk EG0013 affected102 at risk EG0025 affected103 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0007 affected102 at risk EG0013 affected102 at risk EG0025 affected103 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0004 affected102 at risk EG0013 affected102 at risk EG0023 affected103 at risk EG003
Cystitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0012 affected102 at risk EG0021 affected103 at risk EG003
Influenza	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0012 affected102 at risk EG0020 affected103 at risk EG003
Sinusitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0006 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0012 affected102 at risk EG0021 affected103 at risk EG003
Cellulitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0012 affected102 at risk EG0021 affected103 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0022 affected103 at risk EG003
Localised infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Lower respiratory tract infection viral	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Otitis externa	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Otitis media	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Skin infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Tooth infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Body tinea	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0022 affected103 at risk EG003
Ear infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0011 affected102 at risk EG0022 affected103 at risk EG003
Eyelid infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Gingivitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Hordeolum	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Labyrinthitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Lower respiratory tract infection bacterial	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Meningitis viral	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Oral herpes	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Oral infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Paronychia	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Pneumonia	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Pustule	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Pyelonephritis chronic	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Rhinitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Tonsilitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Wound infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Focal nodular hyperplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Lipoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Renal hamartoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Eosinophilia	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Lymphadentis	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Allergy to chemicals	Immune system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0022 affected103 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Hypogonadism	Endocrine disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Adrenal mass	Endocrine disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Goitre	Endocrine disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0012 affected102 at risk EG0020 affected103 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0012 affected102 at risk EG00211 affected103 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0012 affected102 at risk EG0020 affected103 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Feeding disorder	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Hyperamylasaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0022 affected103 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Stress	Psychiatric disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Depression	Psychiatric disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Emotional distress	Psychiatric disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Libido decreased	Psychiatric disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0007 affected102 at risk EG0016 affected102 at risk EG00210 affected103 at risk EG003
Dizziness	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0006 affected102 at risk EG0012 affected102 at risk EG00210 affected103 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Somnolence	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0012 affected102 at risk EG0020 affected103 at risk EG003
Ageusia	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Amnesia	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Nerve compression	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Tremor	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Lethargy	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Migraine	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Presyncope	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Sciatica	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Syncope	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Visual field defect	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Vision blurred	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Cataract	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Eye irritation	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Astigmatism	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Conjunctival irritation	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Eye pain	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Eye pruritus	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Eyelids pruritus	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Papilloedema	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Blepharitis	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Blepharospasm	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Eyelid cyst	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Glaucoma	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Hypermetropia	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Hypoaesthesia eye	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Macular degeneration	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Ocular hypertension	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Presbyopia	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Retinopathy hypertensive	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Visual impairment	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0022 affected103 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Vertico	Ear and labyrinth disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0022 affected103 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0014 affected102 at risk EG0020 affected103 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0012 affected102 at risk EG0024 affected103 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Palpitations	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Bundle branch block left	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Bundle branch block right	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Extrasystoles	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0012 affected102 at risk EG0020 affected103 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Ventricular septal defect acquired	Cardiac disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Hypertension	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0004 affected102 at risk EG0018 affected102 at risk EG0023 affected103 at risk EG003
Aortic arteriosclerosis	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Hot flush	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Subclavian artery occlusion	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Essential hypertension	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Hypertensive urgency	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Hypotension	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0022 affected103 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Phlebitis	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Varicose vein	Vascular disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0011 affected102 at risk EG0022 affected103 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Nasal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0011 affected102 at risk EG0024 affected103 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0022 affected103 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0009 affected102 at risk EG0019 affected102 at risk EG00217 affected103 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0016 affected102 at risk EG00215 affected103 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0006 affected102 at risk EG0019 affected102 at risk EG00214 affected103 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0015 affected102 at risk EG0027 affected103 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0013 affected102 at risk EG0028 affected103 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0014 affected102 at risk EG0025 affected103 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0022 affected103 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0011 affected102 at risk EG0024 affected103 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0017 affected102 at risk EG0026 affected103 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0016 affected102 at risk EG0022 affected103 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0023 affected103 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0004 affected102 at risk EG0014 affected102 at risk EG0021 affected103 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Glossitis	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Oral mucosal discolouration	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Anal incontinence	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Loose tooth	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Pancreatic steatosis	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Rectal polyp	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0004 affected102 at risk EG0012 affected102 at risk EG0022 affected103 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0012 affected102 at risk EG0020 affected103 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Hepatic cyst	Hepatobiliary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Pruritus allergic	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0011 affected102 at risk EG0024 affected103 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0022 affected103 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0005 affected102 at risk EG0013 affected102 at risk EG0022 affected103 at risk EG003
Athralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0007 affected102 at risk EG0014 affected102 at risk EG0021 affected103 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Ankle impingement	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0012 affected102 at risk EG0020 affected103 at risk EG003
Axillary mass	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Joint hyperextension	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0012 affected102 at risk EG0024 affected103 at risk EG003
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0004 affected102 at risk EG0013 affected102 at risk EG0021 affected103 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Polyuria	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Diabetic nephropathy	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Hypertonic bladder	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Ketonuria	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Leukocyturia	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Mixed incontinence	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Renal pain	Renal and urinary disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Haematospermia	Reproductive system and breast disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Scrotal cyst	Reproductive system and breast disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Injection site pain	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0006 affected102 at risk EG0019 affected102 at risk EG00211 affected103 at risk EG003
Fatigue	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0013 affected102 at risk EG0024 affected103 at risk EG003
Injection site bruising	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0013 affected102 at risk EG0022 affected103 at risk EG003
Asthenia	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0023 affected103 at risk EG003
Chest pain	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0011 affected102 at risk EG0023 affected103 at risk EG003
Influenza like illness	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Injection site discomfort	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0022 affected103 at risk EG003
Injection site haemorrhage	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Injection site inflammation	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Injection site mass	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Injection site paraesthesia	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Injection site pruritus	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Injection site swelling	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Thirst	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Chest discomfort	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Chills	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Drug intolerance	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Feeling hot	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Injection site hypersensitivity	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Injection site vesicles	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Malaise	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0022 affected103 at risk EG003
Medical device site reaction	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Medical device site vesicles	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Peripheral swelling	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Swelling face	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Lipase increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0018 affected102 at risk EG0025 affected103 at risk EG003
Weight decreased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0012 affected102 at risk EG0022 affected103 at risk EG003
Amylase increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Blood pressure increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Body temperature increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Electrocardiogram ambulatory abnormal	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Haemoglobin increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
High density lipoprotein increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Prostatic specific antigen increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Weight increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
White blood cells urine positive	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0012 affected102 at risk EG0021 affected103 at risk EG003
Blood calcitonin increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Blood glucose increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Blood potassium increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Blood urine present	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Gastric pH decreased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Glomerular filtration rate decreased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Liver function test increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Pancreatic enzymes increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Transaminases increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Vitamin D decreased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
White blood cell count decreased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0003 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Animal scratch	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Bone contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0022 affected103 at risk EG003
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Respiratory tract procedural complication	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Chest injury	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0002 affected102 at risk EG0012 affected102 at risk EG0020 affected103 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0021 affected103 at risk EG003
Muscle injury	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0012 affected102 at risk EG0020 affected103 at risk EG003
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0020 affected103 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0010 affected102 at risk EG0021 affected103 at risk EG003
Splinter	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0001 affected102 at risk EG0011 affected102 at risk EG0020 affected103 at risk EG003

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Title	Description
BG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous
BG001	Efpeglenatide 2 mg	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
BG002	Efpeglenatide 4 mg	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
BG003	Efpeglenatide 6 mg	Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	0	102	9	102	70	102
EG001	Efpeglenatide 2 mg	Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	0	102	11	102	69	102
EG002	Efpeglenatide 4 mg	Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	0	103	6	103	73	103
EG003	Efpeglenatide 6 mg	Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	1	99	6	99	77	99